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Computerized Systems Used In Clinical Investigations 2007
Electronic Records; Electronic Signatures (21 CFR Part 11)
Human Subject Protection (Informed Consent) (21 CFR Part 50)
Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (Interim Rule) (21 CFR Part 50, subpart D)
Financial Disclosure by Clinical Investigators (21 CFR Part 54)
Institutional Review Boards (21 CFR Part 56)
Forms 1571 (Investigational New Drug Application) and 1572 (Statement of Investigator)
Investigational Device Exemptions (21 CFR Part 812)
Premarket Approval of Medical Devices (21 CFR Part 814
Quality Systems Regulations (21 CFR Part 820)
Addendum to the Instructions for Completing FDA form 3500A with Coding Manual (MEDWATCH)(MDR)
Guidance for Industry: Medical Device Reporting - Alternative Summary Reporting (ASR) Program
Guidance on Adverse Event Reporting for Hospitals that Reprocess Devices Intended by the Original Equipment Manufacturer for Single Use
Instructions for Completing Form 3417: Medical Device Reporting Baseline Report [MDR]
MDR Guidance Document No. 1 - IOL - E1996004
Medical Device Reporting - Remedial Action Exemption; Guidance for Industry and FDA
Medical Device Reporting for Manufacturers
Medical Device Reporting for User Facilities
Medical Device Reporting: An Overview
Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers
Variance from Manufacturer Report Number Format
Variance from Manufacturer Report Number Format [MDR letter]